Cognitive Behavioral Therapy and Real-Time Pain Management Intervention for Sickle Cell Via Mobile Applications (CaRISMA)

• ClinicalTrials.gov Identifier: NCT04419168
• Recruitment Status: Active, not recruiting
• First Posted: June 5, 2020
• Last Update Posted: January 9, 2023
• Sponsor: University of Pittsburgh
• Information provided by (Responsible Party): Kaleab Abebe, PhD, University of Pittsburgh

Tracking Information

• First Submitted Date: May 28, 2020
• First Posted Date: June 5, 2020
• Last Update Posted Date: January 9, 2023
• Actual Study Start Date: August 12, 2020
• Estimated Primary Completion Date: November 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 4, 2020)

Change in Pain interference [ Time Frame: 3, 6, 12 months ]

- PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference Scale a validated questionnaire that assesses how day-to-day function is altered by pain. Range 8-40, higher scores may mean that pain limits your activity level and enjoyment of certain activities

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 4, 2020)

Change in Daily pain intensity [ Time Frame: 3, 6, 12 months ]

Daily pain intensity: 3, 6 and 12-month change in average daily pain intensity "Using any number from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable, what is your pain level today?"

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Cognitive Behavioral Therapy and Real-Time Pain Management Intervention for Sickle Cell Via Mobile Applications
• Official Title: Cognitive Behavioral Therapy and Real-Time Pain Management Intervention for Sickle Cell Via Mobile Applications
• Brief Summary: The investigators are conducting a comparative effectiveness trial among adult patients with sickle cell disease (SCD) who report chronic pain (N = 350), randomized to receive either mobile phone-delivered computerized cognitive behavioral therapy (cCBT; n = 175) or digital education (m-Education; n = 175). Both intervention groups will receive weekly (more frequent if requested or needed) follow-up with a health coach for at least 3 months to reinforce learned materials. Both groups will also use their mobile device to track daily pain, mood, and medication used for two-week periods at baseline and each of the follow-up points (3, 6 and 12 months). Participants will also be given access to a study-associated online support group page where members can discuss with other patients, issues participants faced and what skills were or could be used to address them. Participants will continue all routine care including opioid pain management and novel therapies.

Detailed Description

The study interventions are both Internet-delivered, evidence-based tools that have been tailored specifically for the target population through a user-centered approach that has engaged stakeholders at each stage of the process.

1. Computerized cognitive behavioral therapy (cCBT) for pain. The cCBT program will teach users how to recognize negative thoughts and emotions, use cognitive skills and problem-solving, and apply coping behaviors such as distraction, activity scheduling, and relaxation. The cCBT arm emphasizes skills acquisition and learning through practice; this intervention is consistent with the tailored behavioral services patients would receive individually or as a group when working with a psychologist or behavioral pain specialist.
2. Mobile-delivered pain and sickle cell disease education (m-Education). The m-Education program will teach users about chronic pain, healthy lifestyle tips (e.g., nutrition and exercise), and facts about SCD. This program is consistent with the education patients and families would receive with a patient educator.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

comparative effectiveness trial

Masking: Single (Participant)
Primary Purpose: Treatment

Condition

• Chronic Pain
• Depression, Anxiety
• Opioid Use

Intervention

• Other: cCBT
  A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.
• Other: m-Education
  A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.

Study Arms

• Experimental: cCBT
  Computerized cognitive behavioral therapy (cCBT) for pain. The cCBT program will teach users how to recognize negative thoughts and emotions, use cognitive skills and problem-solving, and apply coping behaviors such as distraction, activity scheduling, and relaxation. The cCBT arm emphasizes skills acquisition and learning through practice; this intervention is consistent with the tailored behavioral services patients would receive individually or as a group when working with a psychologist or behavioral pain specialist.
  Intervention: Other: cCBT
• Experimental: m-Education
  Mobile-delivered pain and sickle cell disease education (m-Education). The m-Education program will teach users about chronic pain, healthy lifestyle tips (e.g., nutrition and exercise), and facts about SCD. This program is consistent with the education patients and families would receive with a patient educator.
  Intervention: Other: m-Education
• No Intervention: Convenience Comparison
  Not participating in the intervention. Participants will complete the baseline questionnaire battery only and we will abstract their medical record data for the 12-months before enrollment and 12-months post enrollment.

• Publications *: Badawy SM, Abebe KZ, Reichman CA, Checo G, Hamm ME, Stinson J, Lalloo C, Carroll P, Saraf SL, Gordeuk VR, Desai P, Shah N, Liles D, Trimnell C, Jonassaint CR. Comparing the Effectiveness of Education Versus Digital Cognitive Behavioral Therapy for Adults With Sickle Cell Disease: Protocol for the Cognitive Behavioral Therapy and Real-time Pain Management Intervention for Sickle Cell via Mobile Applications (CaRISMA) Study. JMIR Res Protoc. 2021 May 14;10(5):e29014. doi: 10.2196/29014.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: June 4, 2020): 350
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 2023
• Estimated Primary Completion Date: November 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• People with any type of sickle cell disease
• Male or female, age 18 years or older
• Reports chronic pain: i.e pain more days that not for the past 3 months or longer and/or is prescribed daily or long-acting opioids for pain.
• English speaking

Exclusion Criteria:

• Any potential participants who fail consent comprehension questions

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04419168
• Other Study ID Numbers: STUDY20110346; CER-2018C2-13320 20 ( Other Grant/Funding Number: PCORI )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Kaleab Abebe, PhD, University of Pittsburgh
• Original Responsible Party: Charles Jonassaint, University of Pittsburgh, Assistant Professor
• Current Study Sponsor: University of Pittsburgh
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Pittsburgh
• Verification Date: January 2023